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Acute Mountain SicknessPhase 1SEAWARDIINCT03828474

Sickness Evaluation at Altitude With Acetazolamide at Relative Doses

A Phase 1 study testing Acetazolamide Pill in people with Acute Mountain Sickness, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The specific aim of this study is to evaluate whether acetazolamide 125mg daily is no worse than acetazolamide 250mg daily in decreasing the incidence of acute mountain sickness (AMS) in travelers to high altitude. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Acute Mountain Sickness
What is being tested?
Acetazolamide Pill
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteUnited States
Study dates
9 Aug 2019to 29 Sep 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Able to complete moderate hike at altitude
  • Live at elevation < 4,000 ft
  • Able to arrange own transportation to study site
  • Available for full study duration (Friday night - Sunday morning)

Who cannot join

  • Pregnancy
  • Slept at altitude > 4,000 ft within 1 week of study
  • Allergy to acetazolamide or sulfa drugs
  • NSAIDs, acetazolamide, or corticosteroids within 48 hours prior to study start
  • History of severe anemia, severe heart disease, advanced COPD/emphysema or sickle cell disease

Trial locations and contacts

1 site in 1 country.

United States1 site
  • White Mountain Research Center

    Bishop, California, 93514

Other trials in United States

About this study

The specific aim of this study is to evaluate whether acetazolamide 125mg daily is no worse than acetazolamide 250mg daily in decreasing the incidence of acute mountain sickness (AMS) in travelers to high altitude. The study population is hikers who are ascending at their own rate under their own power in a true hiking environment at the White Mountain Research Station, Owen Valley Lab (OVL) and Bancroft Station (BAR), Bancroft Peak, White Mountain, California

Read the detailed description

Acute mountain sickness (AMS) is a constellation of symptoms including headache, sleep disturbance, fatigue, dizziness, and nausea, vomiting, or anorexia that commonly occurs in travelers ascending to altitudes above 2,500m. AMS incidence varies based on altitude and ascent profile with rates reported from 25 to 75% in tourists, trekkers, and mountaineers at North American altitudes. Symptom onset is typically six to twelve hours after arrival at high altitude. This self-limited disease can be debilitating when severe, and left unrecognized or untreated may progress to potentially fatal high altitude cerebral edema (HACE). While gradual ascent has proven effective in preventing AMS, this approach is often impractical to recreationists, search and rescue, disaster relief, and military operations.

Acetazolamide increases minute ventilation by 10-20% in subjects at altitude, and hastens acclimatization. It is well established that acetazolamide's main site of action is in the kidney, where it generates a metabolic acidosis through renal bicarbonate wasting and attenuates the effects of hypoxemic-induced respiratory alkalosis. Recommended dosing of acetazolamide for AMS prophylaxis has significantly decreased since early days of use in the 1960s. The current recommended dose of acetazolamide for this indication is 125 mg twice daily, as opposed to historical recommendations of 500mg or 750mg daily. Multiple meta-analyses have concluded that when compared with higher doses, 250mg of acetazolamide daily has been shown to be equally efficacious, with the added benefit of decreasing side effects including paresthesias and dysgeusia. A randomized controlled trial confirmed effectiveness of acetazolamide 125mg twice daily in prevention of AMS when started prior to ascent. In this study, it was found that 125mg twice daily corresponded to a range of 3-5mg/kg/day, depending on subject weight. Within this range, those on the lower dosing range did not have a greater incidence or severity of AMS. For subjects weighing between 50kg (110 lbs) - 83kg (183 lbs), a dose of 250mg/day acetazolamide would fall in this range. Interestingly, mountaineers and trekkers have anecdotally reported protection against AMS with 125mg/day of acetazolamide, a dose below 3-5mg/kg for anyone over 41kg (91lb).

Finding the lowest effective dose of acetazolamide for AMS prophylaxis is important because side effects of this medication can mimic AMS, decreasing the specificity of disease scoring on the validated Lake Louise Questionnaire (LLQ) and subsequent AMS diagnosis and chemoprophylactic effectiveness.Keeping in mind that LLQ is scored based on symptoms of headache, gastrointestinal symptoms, fatigue and weakness, and dizziness and lightheadedness, whatever effect acetazolamide has on AMS prevention may be obscured by its side effects that mimic the very same disease. Falsely positive LLQ scores in trekkers and mountaineers taking acetazolamide prophylaxis may lead to unnecessary pharmacologic treatment or even evacuation. From the perspective of high altitude research, participants randomized to or already taking acetazolamide may skew study results by decreasing LLQ specificity and potentially leading researchers to overestimate incidence of AMS.

Being tested
Acetazolamide Pill
Keywords
acetazolamide, chemoprophylaxis, altitude
Medical subject headings
Altitude Sickness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acetazolamide PillDrug

    Also called Diamox

    Acetazolamide pill

Study groups in NCT03828474
Study groupRoleWhat they receive
Acetazolamide 125mg twice dailyExperimentalAcetazolamide pill 125mg twice daily by mouth, started the night prior to ascent and continued for 3 total doses
Receives: Drug: Acetazolamide Pill
Acetazolamide 62.5mg twice dailyExperimentalAcetazolamide pill 62.5mg twice daily by mouth, started the night prior to ascent and continued for 3 total doses
Receives: Drug: Acetazolamide Pill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of acute mountain sickness

    Incidence of acute mountain sickness by Lake Louise Questionnaire

    Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2019
  2. Study start9 Aug 2019
  3. Primary completion29 Sep 2019
  4. Study completion29 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double blind randomized controlled trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03828474
Sponsor's protocol ID
49724
Acronym
SEAWARDII
Status last verified
Feb 2019
First submitted
31 Jan 2019
Last updated
22 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • van Patot MC, Leadbetter G 3rd, Keyes LE, Maakestad KM, Olson S, Hackett PH. Prophylactic low-dose acetazolamide reduces the incidence and severity of acute mountain sickness. High Alt Med Biol. 2008 Winter;9(4):289-93. doi: 10.1089/ham.2008.1029.

    PubMed 19115912
  • Leaf DE, Goldfarb DS. Mechanisms of action of acetazolamide in the prophylaxis and treatment of acute mountain sickness. J Appl Physiol (1985). 2007 Apr;102(4):1313-22. doi: 10.1152/japplphysiol.01572.2005. Epub 2006 Oct 5.

    PubMed 17023566
  • Hackett PH, Roach RC. High-altitude illness. N Engl J Med. 2001 Jul 12;345(2):107-14. doi: 10.1056/NEJM200107123450206. No abstract available.

    PubMed 11450659
  • Lipman GS, Jurkiewicz C, Burnier A, Marvel J, Phillips C, Lowry C, Hawkins J, Navlyt A, Swenson ER. A Randomized Controlled Trial of the Lowest Effective Dose of Acetazolamide for Acute Mountain Sickness Prevention. Am J Med. 2020 Dec;133(12):e706-e715. doi: 10.1016/j.amjmed.2020.05.003. Epub 2020 May 29.

    PubMed 32479750

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Acetazolamide Pill in people with Acute Mountain Sickness, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of acute mountain sickness (time frame: 2 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03828474, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.

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